Pharma Test now offers a test for the direct automatic measurement of softening time of suppositories on the PTZ Auto EZ instrument series in accordance with the new monograph EP 2.9.22.
Whereas the disintegration point of a suppository is relatively straightforward (place in a water bath at 37C and if it doesn't melt then it may not be used for patient application: use the PTS3E instrument for this test), the determination of suppository stability was, up to now, a more complicated job.
Some suppositories may dry out, harden or even shrivel up but the USP has indicated that excessive softening is a major indication of suppository instability.
This would also be indicated by oil staining on packaging.
Pharma Test now offers a test for the direct automatic measurement of softening time of suppositories on the PTZ Auto EZ instrument series in accordance with the new monograph EP 2.9.22.
The SPT-6 is attached to a standard PTZ Auto EZ instrument so that the softening time for each individual test station is automatically recorded, stored and used for batch comparison at a later date (using the PTZ32 software suite).
If a QC application only is needed where individual softening times are not required, then the SPT-6 may also be used in conjunction with the PTZS single station manual disintegration tester.
